Basic Pharmacovigilance in Clinical Trials: common evaluation tools, the responsibility of the promoter

An interactive seminar during which participants will be able to have a regulatory update on current pharmacovigilance obligations in the field of clinical research and an interaction with specialized professionals in the sector, belonging both to the hospital and to the corporate world, with the aim to verify the common tools available to correctly evaluate the PV activities necessary to conduct a clinical trial.

Regulatory overview and planned documentation

Management of reports in eudravigilance

The company experience: from interventional studies to observational requirements

Experience in non-profit studies

Practical exercise: we build a pharmacovigilance estimate

Speakers:

– Mariagrazia Felisi – Clinical Research Director presso CVBF

– Elena Carafelli – CRO Unit Fv Responsible at CTC Policlinico Gemelli

– Pamela Rossi – Pharmacovigilance Safety Unit Manager at Angelini A.C.R.A.F. S.P.A.

– Armando Orlandi – Medical Director Specialist in Medical Oncology at Policlinico Gemelli

– Elena Ottavianelli – Scientific Director AICRO

Target Audience:

Training and updating for professionals working in the field of clinical research, in particular senior CRAs, clinical team leaders, lead CRAs and clinical project managers, researchers in general.

Locations:

Rome – Policlinico Universitario Agostino Gemelli – Training Center (II floor).

Timetable: 11:00 – 16:00

Scheduled: welcome coffee and light lunch

The registration fee is per person:

Fee equal to € 150,00 + revenue stamp (total € 152,00) is due by participants belonging to AICRO member companies (without application of VAT);
Fee equal to € 150,00 + revenue stamp (total € 152,00) is due by participants belonging to the internal staff of Policlinico Universitario Agostino Gemelli;
A fee equal to € 200,00 + VAT (total € 244,00), is payable by participants who are not members of the AICRO.

• Agenda
• Registration form

Reports:

Would you like to view the presentations of the speakers at the event? Click on the button below and access the dedicated area.